Megace 160 mg tablets – patient leaflet, side effects, dosage

1. What Megace tablets are and what they are used for

• impotence

2. What you need to know before you take Megace tablets

• passing wind

3. How to take Megace tablets

• needing to urinate more often

4. Possible side effects

• feeling sick and being sick

5. How to store Megace tablets

• changes in vaginal bleeding (breakthrough bleeding, spotting)

6. Contents of the pack and other information

• build up of fluid which causes swelling (mainly in the ankles)
• What Megace tablets are and what they are used for
• pain

The name of your medicine is Megace tablets. Megace tablets contain the active ingredient megestrol acetate. Megestrol acetate belongs to a group of medicines called progestogens and is used to treat certain types of cancer known as hormone-dependent cancer, which include cancer of the breast.

• rash, including hives or nettle rash (urticaria)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see contact details below). By reporting side effects you can help provide more information on the safety of this medicine.

1. 2. What you need to know before you take Megace tablets

Do not take Megace tablets if you:

Ireland:

• are allergic to megestrol acetate or any of the other ingredients of this medicine (listed in section 6).

  HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

Warnings and precautions

Tell your doctor if you:

United Kingdom:

• have severe liver problems

  Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

• currently suffer from, or have a history of suffering from blood clots (thrombophlebitis)

• have diabetes, as Megace tablets can increase your blood sugar levels

  1. 5. How to store Megace tablets

If you are over 65 years of age your doctor may want to monitor your kidney function from time to time, as this can sometimes decrease with age.

Do not store above 25°C. Store in the original package in order to protect from moisture. They should not get too hot or damp; so do not leave your tablets near a radiator, on a window sill or in the bathroom. Please check the expiry date of the product, shown on the carton and blister of Megace tablets. Do not use after the month stated.

Other medicines and Megace tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding

Keep this medicine out of the sight and reach of children.

Do not take Megace tablets if you are pregnant, think you may be pregnant, or if you are breast-feeding. Driving and using machines

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Megace tablets do not usually affect your ability to drive.

Megace tablets contains lactose

1. 6. Contents of the pack and other information

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

What Megace tablets contain

Each Megace tablet contains 160 mg of the active ingredient megestrol acetate. The other ingredients are: microcrystalline cellulose, lactose monohydrate 224.5 mg, magnesium stearate, povidone, colloidal anhydrous silica, and sodium starch glycolate.

1. 3. How to take Megace tablets

Always take Megace tablets exactly as your doctor has told you. You should check with your doctor if you are not sure. The usual dosage is 160 mg megestrol acetate per day.

Tablets should be swallowed with a glass of water.

What Megace tablets look like and contents of the pack

This medicine is not recommended for children.

Megestrol acetate tablets (160 mg) are oval shaped biconvex tablets scored on one side and engraved with “160” on the other side and are available in blister packs of 30 tablets.

Megace tablets should be taken for at least two months to see if they are effective. Some patients take them for many years.

Do not stop taking them, unless advised to do so by your doctor.

Marketing Authorisation Holder and Manufacturer

If you take more Megace tablets than you should

Marketing Authorisation Holder

If you take more Megace than you should, go to your nearest hospital emergency department or contact your doctor immediately.

IE:

P1UK01 UK:

Bausch and Lomb UK Ltd.

PharmaSwiss Česká republika s.r.o.,

Take the empty container and any remaining medicine with you.

Bausch & Lomb House

Jankovcova 1569/2c

170 00, Prague 7

106 London Road

If you forget to take Megace tablets

Czech Republic

If you miss a dose, do not worry. If you remember within a few hours of the missed dose take it as soon as possible, but if it is almost time for your next dose then skip the forgotten one and continue as before. Do not take a double dose to make up for the one you missed.

Manufacturer

Haupt Pharma Amareg GmbH

1. 4.

   Possible side effects

   Donaustaufer Strasse 378

   93055 Regensburg, Germany

As with all medicines, Megace can cause side effects although not everybody gets them. If you notice any of the following, stop taking Megace and contact your doctor immediately:

This leaflet was last revised in September 2020

• swelling of the face, lips, or tongue
• skin rash
• difficulty breathing

As these may be signs of an allergic reaction.

P1UK01